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NCT Number: NCT04705246

Role of Exposure in Hyperacusis

This study focuses on patients with a primary complaint of hyperacusis. Hyperacusis has been defined as 'abnormally reduced tolerance to sound'. It shows a high comorbidity with tinnitus, the perception of sound in the absence of a sound source. For the period of one month, hyperacusis and tinnitus severity and exposure to sounds will be evaluated by use of Ecological Momentary Assessment (EMA) in all participants. A novel approach to assessments, EMA prompts participants during their daily life to answer short questionnaires, increasing ecological validity and minimizing the risk for recall and memory biases. At a randomized time point during the one-month period, participants will individually receive a single psychoeducation session (1h) delivered by an experienced audiologist. The goal of the study is to investigate if the psychoeducation session leads to an increase in exposure to sound and a decrease in hyperacusis severity.

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Key information

Conditions

Hyperacusis Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary complaint of hyperacusis

Exclusion criteria

  • primary complaint of misophonia
  • primary complaint of tinnitus
  • undergoing another therapy at the moment of the study

Treatment and study plan

Psychoeducation

Behavioral

The goal of the psychoeducation session is to provide insight in the hyperacusis symptoms, take away the fear of external noises, and encourage exposure to noise.

Primary outcomes

  1. Change in EMA questions from baseline to end of the study

    Time frame: 8 random time points each day during the period of the study, from baseline and after intervention, though study completion for an average of 1 month

    Change in questions concerning exposure, hyperacusis and tinnitus during the day from baseline measurement to last day of the study period

Secondary outcomes

  1. Hyperacusis Questionnaire

    Time frame: before intervention, immediately post intervention

    Hyperacusis severity self-report questionnaire, ranging from 0-42 with a higher score representing a higher sensitivity to sounds. A score of 28 is the cut-off for auditory hypersensitivity.

  2. Tinnitus Functional Index (TFI)

    Time frame: before intervention, immediately post intervention

    Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus

Study contacts

Contact information is provided by the study sponsor or research team.

Laure Jacquemin, PhD

CONTACT

[email protected]

038214233

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Universiteit Antwerpen

Registry information

Official study title

Effect of Psychoeducation Upon Exposure to Sounds and Hyperacusis Severity

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Jan 12, 2021
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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